|
Item |
Standard |
Results |
Remark |
|
|
Appearance |
White, crystalline granules or as a granular powder |
Conforms |
|
|
|
Assay |
97.5-102.0% |
99.5% |
|
|
|
Water |
≤1.0% |
0.1% |
|
|
|
Soluble starch, sulfite |
≤15ppm |
＜15ppm |
|
|
|
Related substances |
Maltose and isomaltose: ≤0.4% |
＜0.40% |
|
|
|
Maltotriose: ≤0.2% |
＜0.2% |
|
||
|
Fructose: ≤0.15% |
＜0.15% |
|
||
|
Unspecified impurities: ≤0.10% |
＜0.10% |
|
||
|
Total impurities: ≤0.5% |
＜0.5% |
|
||
|
Conclusion |
The batch product complies with USP41 |
|||
